AMG 853 Phase 2 Study in Subjects With Inadequately Controlled Asthma

Official Title: “A Randomized, Double-Blind, Placebo Controlled, Multiple Dose Phase 2 Study to Determine the Safety and Efficacy of AMG 853 in Subjects With Inadequately Controlled Asthma”

The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12.

Intervention(s) in this Clinical Trial

• Drug: AMG 853
  • AMG 853 5 mg (BID)
• Drug: AMG 853
  • AMG 853 200 mg (QD)
• Drug: AMG 853
  • AMG 853 25 mg (BID)
• Drug: AMG 853
  • AMG 853 100 mg (BID)
• Drug: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: AMG 853
• Placebo Comparator: Placebo

Primary Measures

• The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12.
  • Time Frame: Baseline to Week 12
    Safety Issue?: No

Secondary Measures

• Evaluate the efficacy of AMG 853 as measured by use of rescue short-acting β-agonist (SABA)
  • Time Frame: Baseline to Week 12
    Safety Issue?: No
• Evaluate the efficacy of AMG 853 as measured by daily symptom score (aggregate/night and individual symptoms; and symptom free days)
  • Time Frame: Baseline to Week 12
    Safety Issue?: No
• Evaluate the efficacy of AMG 853 as measured by pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1)
  • Time Frame: Baseline to Week 12
    Safety Issue?: No
• Evaluate the efficacy of AMG 853 as measured by AM and PM peak expiratory flow rate (PEFR)
  • Time Frame: Baseline to Week 12
    Safety Issue?: No
• Evaluate the efficacy of AMG 853 as measured by asthma quality of life questionnaire (AQLQ)
  • Time Frame: Baseline to Week 12
    Safety Issue?: No

Inclusion Criteria:

• Males or females 18 to 65 years of age
• Percent of predicted FEV1 ≥ 50% and ≤ 80%
• At least 12% reversibility over pre-bronchodilator FEV1
• Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone or equivalent.
• Ongoing asthma symptoms with ACQ score ≥ 1.5 points

Exclusion Criteria:

• History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
• Any uncontrolled, clinically significant systemic disease
• Respiratory infection within 4 weeks of the screening visit

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Amgen Industry

Overall Clinical Trial Officials and Contacts

MD Study Director Amgen  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01018550

Study ID Number: 20080615

ClinicalTrials.gov Identifier: NCT01018550

Health Authority: United States: Food and Drug Administration

AmgenTrials clinical trials website